Application 050634

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No
002	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	Yes	No
003	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050634-001	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28
N050634-002	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28
N050634-003	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-112	FORTAZ	ceftazidime sodium	Teligent Pharma, Inc.	NDA	Current
52565-113	FORTAZ	ceftazidime sodium	Teligent Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49191	SUPPL	2017-08-02
49160	SUPPL	2017-07-31
39061	SUPPL	2014-09-26
30201	SUPPL	2014-09-26
30200	SUPPL	2007-07-16
39060	SUPPL	2007-07-10
39059	SUPPL	2007-03-15
30199	SUPPL	2007-03-15
39058	SUPPL	2004-05-27
7913	SUPPL	2004-05-26
30197	SUPPL	2002-03-29
17957	SUPPL	2002-03-29
30198	SUPPL	2002-03-22